Downloaded 35 times
Uploaded byInstantGMP™
InstantGMP Compliance Series - Testing
The document outlines compliance issues in cGMP testing for dietary supplements, highlighting a specific FDA warning to a lab for failing to test the identity of dietary ingredients as required by regulations. It discusses the importance of rigorous testing to ensure product quality, safety, and adherence to specifications for various dietary components. Additionally, it covers responsibilities for sponsors and quality control personnel in testing finished products and emphasizes the necessity of valid testing methods.
More Related Content
Similar to InstantGMP Compliance Series - Testing
InstantGMP Compliance Series - Testing
- 1. InstantGMP Compliance Series forcGMP Dietary Supplements Testing
- 2. GMP Testing Problems •FDA issued warning letter to neutaceutical lab • Firm failed to test identity of each dietary ingredient • Requited by 21 CFR 111 – GMP regulations for dietary supplements • Failure to correct could result in enforcement actions • E.g. seizures of products or injunction against further manufacturing Electronic cGMP Manufacturing Execution System
- 3. Why Testing IsImportant • GMP requirement • Attributes tested to show: – Potency – Strength – Identity = proper composition – Free from impurities or adulteration • Guarantees quality of product • Provides proof consumer needs to know product is useful and not harmful Electronic cGMP Manufacturing Execution System
- 4. Tests and SpecificationsNeeded For: • Components • In-process production • Labels and packaging • Finished batch of dietary supplement • Product received from a supplier for packaging and labeling • Packaging and labeling for the finished dietary supplement Electronic cGMP Manufacturing Execution System
- 5. Product Specifications • Specificationsfor finished batch of dietary supplements • Identity • Purity • Strength • Composition • Limits for possible contaminants Electronic cGMP Manufacturing Execution System
- 6. Testing Dietary Ingredients • Each dietary ingredient has to be tested for identity – Chose: – Gross organoleptic analysis – Macroscopic analysis – Microscopic analysis – Chemical analysis – Other scientifically valid methods. • May not use CoA from suppliers Electronic cGMP Manufacturing Execution System
- 7. Vitamin and MineralsTests • Identification • Assay • Appearance • Odor • Solubility • Melting Point • Loss on Drying or Residue on Ignition • Heavy Metals • Organic Volatile Impurities Electronic cGMP Manufacturing Execution System
- 8. Botanicals Tests • Identityof a botanical may include: – Part of the plant (e.g., roots or leaves) – Color – Odor • Whether the part of the plant is in a native state or has been ground up • Characteristics that differentiate botanical from related species Electronic cGMP Manufacturing Execution System
- 9. Sponsor’s Responsibility • Testingand Release of Final Product • Samples pulled from production batch • QC will test according to methods in specifications • IQA will disposition batch after final product testing • Products received for packaging and labeling must be tested to ensure it matches purchase order Electronic cGMP Manufacturing Execution System 9
- 10. Some Tests &Specs Not Needed • Aesthetic appearance of dietary supplement • Various constituents that are normally present in a natural product • Dissolution • Disintegration • Bioavailability • Premature to impose requirements in areas where science is still evolving Electronic cGMP Manufacturing Execution System
- 11. Quality Testing Request InstantGMPgenerates testing request form that can be sent with sample to QC 11
- 12. InstantGMP™ Find more presentationson cGMP Compliance for Dietary Supplements in the Resource Center at www.instantgmp.com
Editor's Notes
- #2 The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the GMP procedures for testing dietary supplement products.
- #3 The FDA inspects dietary supplement manufacturers to ensure they are in cGMP compliance. After they inspected Sterling USA Neutraceutical Lab (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm332828.htm) they cited them for failing to conduct at least one test or examination that would verify the identity the dietary ingredients used in their products. Testing each dietary ingredient prior to its use is required by 21 CFR 111.75(a)(1)(i). If they do not promptly correct the violations enumerated in the warning letter, the FDA could start enforcement action without further notice. Enforcement action may include seizure of the cited products and/or injunction against the manufacturers and distributors of these products.
- #4 There are many GMP requirements for tests and specifications for dietary supplement products. The attributes of a product are tested to show that the product is potent, it has the right strength, it has the proper composition according to its label and that is free from impurities or adulteration. These are important to guarantee the quality of the final product. Proof of these attributes are what the consumer must rely on so they are sure that the product will be useful and not harmful to their health. Testing is what provides the proof.
- #5 GMP regulations require tests and specifications for components, in-process production, labels and packaging, the finished batch of dietary supplement, product received from a supplier for packaging and labeling, and the packaging and labeling for the finished packaged and labeled dietary supplement. There must be tests and specifications necessary to prevent adulteration as a result of manufacturing operation and not as a result of contaminants from the components. For example, a certain piece of equipment might have to be cleaned or sanitized after handling certain raw materials that might have microbial contamination.
- #6 Product specifications are identity, purity, strength, and composition and the limits for possible contaminants for a finished batch of dietary supplement. The identity specification is especially important to ensure that the finished dietary supplement has the right composition. Many dietary supplements contain a variety of ingredients especially if they come from a natural source so you could not know what your final product contains if you do not know what you put into it.
- #7 The FDA requires that each incoming dietary ingredient is tested or examined for identity. It is up to each firm to decide which test is scientifically valid. It may be a gross organoleptic analysis, a macroscopic analysis, a microscopic analysis or a chemical analysis. In any event, f irms may not use a certificate of analysis from the supplier. An organoleptic analysis may be appropriate for whole or coarsely-cut botanical parts, however it may not be appropriate for powdered or extracted botanicals because processing may change their odor.
- #8 The incoming test for vitamins or minerals might include a combination of various tests, for example: Identification Assay Appearance Odor Solubility Melting Point Loss on Drying or Residue on Ignition Heavy Metals Organic Volatile Impurities
- #9 No specifications have to be set for the identity, purity, strength, or composition of the various constituents that are inherently present in a natural product such as a botanical. However, the identity of the botanical has to be confirmed. This could include establishing the identity of the part of the plant used and the color and the odor. A comparison to an authentic representative plant will be useful here.
- #10 Testing and Release of Final Product is the sponsor’s responsibility. Samples are pulled from the production batch and submitted to Quality Control. QC will test the product in accordance with the tests in the specifications. The Quality group at the sponsor’s firm will disposition the batch after the final product is tested. if you receive a product from a supplier for packaging or labeling, you must test to ensure that the product received is consistent with your purchase order.
- #11 Some specifications are not needed for dietary supplements. For example, the aesthetic appearance of a dietary supplement does not need to be evaluated. Tests for dissolution, disintegration, and bioavailability of dietary supplements are examples of areas where scientific study is still evolving and it is premature to impose requirements for these tests. For botanicals, there are a variety of constituents that are normally present in a natural product so specifications are not needed for these.
- #12 InstantGMP is an electronic cGMP manufacturing execution system that includes modules for specification control with tests and methods. The form contains information on handling safety and how to take samples for testing. It also has a list of the required tests, methods and acceptance methods. It make Quality Control test requests easy to create and to use.
- #13 This presentation is just one of many articles, presentations and videos available on cGMP compliance for Dietary Supplements. You can find the rest in the Resource Center at www.InstantGMP.com.